OncoMatch/Clinical Trials/NCT05660395
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
Is NCT05660395 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Loncastuximab Tesirine for diffuse large b-cell lymphoma.
Treatment: Loncastuximab Tesirine — The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Prior therapy
Must have received: systemic therapy
who have received at least one systemic treatment regimen
Cannot have received: antibody-drug conjugate (loncastuximab tesirine)
Previous therapy with loncastuximab tesirine
Cannot have received: stem cell transplant
Exception: within 60 days prior to start of study drug (C1D1)
Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)
Cannot have received: major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy
Exception: within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
Lab requirements
Liver function
normal hepatic function or hepatic impairment as defined by the national cancer institute organ dysfunction working group hepatic impairment classification: arm a normal hepatic function: bilirubin and aspartate aminotransferase (ast) ≤ upper limit of normal (uln); arm b moderate hepatic impairment: bilirubin > 1.5 × to 3 × uln (any ast); arm c severe hepatic impairment: bilirubin > 3 × uln (any ast)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Oncology Institute of Hope & Innovation - Lynwood · Lynwood, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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